All Drugs and Chemicals

Imetelstat

Motesanib diphosphate

Protein Kinase Inhibitors

Enzyme Inhibitors

The dose of AMG 706 will be administered at the same dose level and schedule received at the conclusion of the previous study but will be no greater than 125 mg QD or 75 mg BID.

AMG 706

This is an extension study to provide ongoing treatment with AMG 706 monotherapy for subjects with solid tumors who have completed the planned duration of AMG 706 treatment on a separate Amgen protocol and have been evaluated as having stable disease or better. Subjects who are no longer eligible to continue AMG 706 treatment on a separate Amgen protocol (for reasons other than AMG 706 intolerance), but who are receiving clinical benefit or have the potential to receive clinical benefit from AMG 706 per the investigator are also eligible to participate in this trial.

An Open Label Treatment Extension Study of AMG 706

Amgen

Symptoms and General Pathology

All Conditions

Wounds and Injuries

Infections

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Nervous System Diseases

Blood and Lymph Conditions

Nutritional and Metabolic Diseases

Immune System Diseases

Behaviors and Mental Disorders

Rare Diseases

Syndrome

Necrosis

Hyperthermia

Fever

Brucellosis

Familial Mediterranean Fever

Hereditary Autoinflammatory Diseases

Mevalonate Kinase Deficiency

Amyloidosis

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Genetic Diseases, Inborn

Proteostasis Deficiencies

Metabolic Diseases

Tumor Necrosis Factor Receptor-associated Periodic Syndrome

Mevalonic Aciduria

Pharmaceutical Solutions

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Colchicine

Immunoglobulins

Immunoglobulins, Intravenous

Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.

Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution

Canakinumab (AIN457)

The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.

An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes

An Extension Study of CACZ885N2301 (NCT02059291), Multi-center, Open Label Study of Canakinumab in Japanese Patients With Periodic Fever Syndromes (Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper Immunoglobulin D Syndrome ((Also Known as Mevalonate Kinase Deficiency) (HIDS/MKD), or Colchicine Resistant/Intolerant Familial Mediterranean Fever (crFMF))

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Participants were monitored for safety throughout the study.

Novartis Pharmaceuticals

TRAPS

HIDS

cfFMF

HIDS/MKD

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Study Director

Non-serious adverse events

Serious adverse events

Deaths

Safety set: The safety set included all participants who were treated in this extension study.

Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths

Overall Study

Neoplasms

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antibodies, Bispecific

Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells

Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells

Elranatamab

Pfizer CT.gov Call Center

This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.

This is a single-arm elranatamab post-trial access study. Participants will receive elranatamab. All participants will receive elranatamab until disease progression, unacceptable toxicity, withdrawal of consent, study termination or, elranatamab becomes commercially accessible in the participant's country.

Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)

ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Pfizer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open Label Treatment Extension Study of AMG 706	NCT00360867	Solid Tumors	AMG 706	18 Years -	Amgen
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes	NCT02911857	Periodic Fevers...	Canakinumab (AI...	-	Novartis
Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)	NCT06057402	Multiple Myelom...	Elranatamab	18 Years -	Pfizer
An Open Label Treatment Extension Study of AMG 706	NCT00360867	Solid Tumors	AMG 706	18 Years -	Amgen
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes	NCT02911857	Periodic Fevers...	Canakinumab (AI...	-	Novartis

Spots Global Cancer Trial Database for extension study